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An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04395508
Expanded Access Status : Available
First Posted : May 20, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:

This single arm, multicenter study provides the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer who are currently receiving pertuzumab (Perjeta) and trastuzumab (Herceptin) by intravenous administration (P+H IV). The main objective is to enable continuity of care during the COVID-19 pandemic.

This study will enroll approximately 400 participants with HER2+ breast cancer who have completed concurrent chemotherapy with P+H IV and are currently receiving or will be receiving maintenance therapy with pertuzumab and trastuzumab.

Participants will receive treatment every 3 weeks and continue treatment unless early cessation is necessary due to disease recurrence, disease progression, unacceptable toxicity or participant withdrawal. Only participants with HER2+ early breast cancer will receive PH FDC SC to complete 18 cycles of dual blockade, including the P+H IV they received prior to enrolling in this study.

The Sponsor may decide to terminate the study when PH FDC SC is approved by the FDA and is commercially available and the COVID-19 pandemic is no longer a risk for this patient population.


Condition or disease Intervention/treatment
HER2-positive Breast Cancer Drug: Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC)

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Drug: Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration (PH FDC SC)
    PH FDC SC is given as a fixed dose (i.e. non-weight based) subcutaneous injection. Two dosage configurations of PH FDC SC may be administered in the study: a 15-millilitre (mL) loading dose consisting of 1200 milligrams (mg) pertuzumab and 600 mg trastuzumab and a 10-mL maintenance dose consisting of 600 mg pertuzumab and 600 mg trastuzumab. Participants who have had ≥6 weeks since their last P+H IV or PH FDC SC treatment must receive a loading dose before continuing with maintenance doses for subsequent administrations.
    Other Names:
    • Pertuzumab, Trastuzumab, and Hyaluronidase-ZZXF
    • RO7198574
    • RG6264

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Female or male patients with histologically confirmed human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have completed chemotherapy in combination with Perjeta and Herceptin and are currently receiving maintenance P+H IV (regardless of remaining treatment cycles [e.g., only 1 cycle remaining])
  • HER2+ status must have been previously determined and is defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥ 2 for the number of HER2 gene copies to the number of chromosome 17 copies
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Intact skin at planned site of subcutaneous (SC) injections (thigh)
  • Baseline and most recent (within 3 months) LVEF ≥ 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
  • No major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined in the protocol
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined in the protocol

Exclusion Criteria:

  • Investigational treatment within 4 weeks of enrollment
  • Current or prior history of active malignancy (other than current breast cancer) within the last 5 years. Appropriately treated non-melanoma skin cancer; in situ carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the last 5 years are allowed
  • Any severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)
  • Patients who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their INR
  • Serious cardiac illness or medical conditions
  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
  • Inadequate bone marrow function
  • Impaired liver function
  • Renal function with creatinine clearance <50 mL/min using the Cockroft-Gault formula
  • Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within seven months after the last dose of study treatment
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in, and completion of, the study
  • Known active liver disease, for example, active viral hepatitis infection (i.e., hepatitis B or hepatitis C), autoimmune hepatic disorders, or sclerosing cholangitis
  • Concurrent, serious, uncontrolled infections, or known infection with human immunodeficiency virus (HIV)
  • Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
  • Previously experienced severe injection related reactions with pertuzumab and trastuzumab by intravenous (IV) administration
  • Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent excluding inhaled steroids)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395508


Contacts
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Contact: Reference Study ID Number: AL42478 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. only) global-roche-genentech-trials@gene.com

Locations
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United States, District of Columbia
MedStar Washington Hosp Center Available
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04395508    
Other Study ID Numbers: AL42478
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents